Gelteq Limited (NASDAQ: GELS) has announced the commencement of a preclinical bioequivalence study for its novel gel-based antihistamine formulation, marking a significant step toward addressing unmet needs in the $12 billion global antihistamine market. The study, launched in September 2025, is being conducted by Adgyl Lifesciences, a partner of Eurofins Advinus and leader in preclinical contract research services.
Strategic Regulatory Approach
The company is positioning itself to leverage the FDA's 505(b)(2) regulatory pathway, a streamlined route that could significantly reduce development timelines and costs. According to industry analysis, 505(b)(2) applications typically require 3-5 years of development compared to 10-15 years for traditional new drug applications (NDAs), with costs estimated at $15-100 million versus over $1 billion for conventional pathways.
"Our gel-based delivery platform is expected to transform traditional pharmaceutical products currently available on the market, especially where patient compliance and dosage control are critical," said Nathan Givoni, CEO of Gelteq. "By applying our technology to a well-established antihistamine, we see a significant opportunity to capture value in the allergy market, where patient-friendly formats and flexible dosing remain unmet needs."
Market Opportunity and Clinical Need
The global antihistamine market presents substantial commercial potential, valued at approximately $9 billion in 2023 and growing at a 6% compound annual growth rate, with projections to exceed $12 billion by 2028. Allergic conditions affect over 50 million people annually in the United States alone, with demand spanning pediatric, adult, and increasingly, animal health applications.
Gelteq's proprietary gel formulations are designed to address key limitations of traditional tablets and syrups, including palatability challenges for children, swallowing difficulties for elderly patients, and precise dosing needs in veterinary medicine. The gel's stable matrix enables precise dosing, improved bioavailability, and targeted gastrointestinal release, making it particularly suitable for populations with dietary restrictions or swallowing difficulties.
Technology Platform Advantages
"Our innovative gel technology offers potential advantages in taste masking, ease of administration, and flexible dosing," added Givoni. "These attributes are particularly relevant in pediatrics and veterinary care where delivering effective allergy treatments can be challenging."
The gel-based delivery system is engineered to solve persistent issues in medication adherence that disproportionately affect pediatric, geriatric, and veterinary patients. Traditional antihistamines often face challenges such as bitter taste, choking risks, and difficulty swallowing—barriers that Gelteq's technology aims to overcome.
Manufacturing and Partnership Strategy
Gelteq has established strategic partnerships to support its commercialization efforts, including a collaboration with IDT Australia, which brings 50 years of cGMP-certified manufacturing expertise. This partnership, combined with distribution agreements in the Asia-Pacific region and a U.S. partnership with Healthy Extracts Inc., creates infrastructure for global market entry.
The company has also expanded into China, a market with rising allergy prevalence, further amplifying its growth potential. Recent leadership additions include Dr. Paul Wynne as Chief Scientific Officer and Matthew Jones for sports nutrition, signaling the company's commitment to scientific rigor and strategic expansion.
Regulatory Pathway Benefits
The 505(b)(2) pathway offers Gelteq a cost-effective route to market by leveraging existing safety and efficacy data from previously approved drugs. This approach could allow the company's antihistamine gel formulation to bypass redundant clinical trials, reducing both development timelines and costs. The pathway also provides potential access to market exclusivity in certain cases, such as for new clinical indications, offering competitive advantages similar to those achieved by other companies using this regulatory route.
If preclinical results prove successful, Gelteq anticipates advancing to human clinical trials targeting FDA approval via the 505(b)(2) pathway, positioning the company to capture a significant share of the growing global antihistamine market with its differentiated gel-based solution.
